Concentric loop intrauterine device

ABSTRACT

An intrauterine device comprising two concentric generally circular rings formed of elastic, inert plastic material coupled by a plurality of bridges of similar material. The material is elastically deformed during insertion into the uterine cavity by a specially formed applicator, and magnetic material is imbedded in a normally coiled tab associated with the inner of the two rings for subsequent removal by magnetic extractor means.

United States Patent Ansari 1*Sept. 30, 1975 CONCENTRIC L OOPINTRAUTERINE DEVICE [76] Inventor: Amir H. Ansari. 2484 Stratford Rd.

Cleveland Heights, Ohio 44l l8 Notice: The portion of the term of thispatent subsequent to Apr. 23. 1991, has been disclaimed.

' 22 Filed: Mar. 27, 1974 [2|] Appl. No.: 455,045

Related U.S. Application Data [63] Continuation-impart of Scr. No.273,545, July 20.

i972, Pat. No. 3,805,777

[52] U.S. Cl. 128/130 Int. Cl. A6lF 5/46 [58] Field of Search 128/127,128, 129, 130

[56] References Cited UNITED STATES PATENTS 1786.808 l/l974 Levner128/130 3.8()5 777 4/1974 Ansariun. 128/130 $309,076 5/1974 Chuhon .4128/130 OTHER PUBLICATIONS RCA Technical Notes, RCA TN No. 675, June1966.

Ishihama. Clinical Studies on Intrauterine Rings," Yokohama Med. Bull,Vol. 10, No. 2, April, 1959, pp. lOl.

Primary E\'aminer-Richard A. Gaudet Assistant Examiner-J. C. McGowanAttorney, Agent, or FirmDonnelly, Maky, Renner & Otto 5 7 ABSTRACT Anintrauterine device comprising two concentric generally circular ringsformed of elastic, inert plastic niatcrial coupled by a plurality ofbridges of similar material. The material is elastically deformed duringinsertion into the uterine cavity by a specially formed applicator, andmagnetic material is imbedded in a normally coiled tab associated withthe inner of the two rings for subsequent removal by magnetic extractormeans.

9 Claims, 4 Drawing Figures Sept. 30,1975

U.S Patent CONCENTRIC LOOP INTRAUTERINE DEVICE This application is acontinuation-in-part of my copending patent application for IntrauterineDevice and Means for Inserting and Removing the Same, Ser. No. 273,545,filed July 20, 1972, now U.S. Pat. No. 3,805,777, issued Apr. 23, 1974.

BACKGROUND OF THE INVENTION The present invention relates as indicatedto an improved two-ring intrauterine device and novel means for removingthe device from the uterine cavity. The use of intrauterine devices forconception prevention has long been established, with early efforts inthis field dating back at least sixty years. For one reason or an other,these early developments did not produce an intrauterine devicegenerally acceptable to the medical profession, and the concept untilrecently did not enjoy widespread use for conception preventionpurposes.

In recent years, there has been significant interest in the use of thesedevices, and substantial development has taken place in an effort toprovide a safe and effective intrauterine device. Although indevelopments to date, the shape of the device and the method ofinserting and removing the same have widely differed, there are certaincommon characteristics. The devices are shaped to fit the uterine cavityand to be retained in position within the cavity. A string or tail iscommonly carried by the device and protruding from the external cervicalos is for convenient removal of the device from the cavity. Recentdevelopments in this field have also extensively relied upon the use ofinert plastic material or similarly inert metals, or combinations ofthese materials.

Depite the recent sophistication in the materials employed inmanufacturing the devices, and the techniques and methodology employedin inserting and removing the same from the uterine cavity, the use ofpresently available intrauterine devices have been attended by certaindisadvantages and complications. Some of the more common complicationsassociated with use of the devices are pelvic infection, chroniccervicitis, excessive uterine bleeding, spontaneous ex pulsion,abdominal cramping, and irregular bleeding. Another disadvantage withconventional intrauterine devices is that they may become lost withinthe abdominal cavity and, being normally non-metallic, such a lostdevice is difficult or even impossible to locate. It is understandablethat the presence of one or more of these complications frequently leadsto the request from the patient that the device be temporarily orpermanently removed.

My personal experience with presently available intrauterine devicesover the past several years leads to the conclusion that the primarydifficulties are to a great extent due to the attached string or tailcarried by the device for removable purposes, and the use of materialswhich result in the above noted complications.

Certain of the problems resulting from the presence of a string or tailcarried by the intrauterine device include local irritation of thecervix and vagina which can ultimately lead to cervico-vaginitis,ascending infection with ultimate development of pelvic inflammatorydiseases, and the ability to provide directional guidance of the devicetoward the vagina thereby resulting in spontaneous expulsion of thedevice.

Moreover, it is desirable and often essential that the diameter orexternal periphery of an intrauterine device have a sufficiently largedimension to assure adequately accomplishing its intended function; yetthe interior of such devices should preferably be open or free ofmaterial to permit otherwise normal uterine body functions. A largediameter interiorly open ring-type intrauterine device, however, ispotentially hazardous if it somehow penetrates the uterine wall andenters the abdomen, for the large diameter opening thereof would becapable of bowel strangulation or the like.

As above indicated, it is extremely important that the material employedfor the device be environmentally compatible, that is, that the materialof the device does not adversely affect the surrounding environment, ordoes not suffer significant deterioration because of such environment,keeping in mind that the device is continually exposed to bodytemperatures. Where improper materials are employed, local irritationmay result causing lower abdominal cramping and discomfort, and evenpossibly leading to the development of endometritis. The foreign natureof the material may also cause excessive uterine bleeding, and may causeinvoluntary expulsion of the device due to excessive uterinecontractions. A further cause for concern in regard to the materialsemployed is the long term affects the use of such materials may have onthe uterine cavity.

SUMMARY OF THE INVENTION With the above in mind, a primary object of thepresent invention is to provide an intrauterine device the shape andmaterial of which substantially eliminates the problems above mentioned.

Another object of the present invention is to provide such a device inwhich an inert plastic material is employed in the form of twoconcentric rings which is totally free of a string or tail of the typereferred to above and which has a large amount of free or open spacewithin the outer periphery defining the same.

A further object of the present invention is to provide an intrauterinedevice which can be deformed to the desired shape to facilitateinsertion of the device into the uterine cavity, and which is providedwith means for locating and removing the device from the cavity. Inaccordance with the present invention, means in the form of a magneticmember or' members are associated with the ring thereby facilitatinglocation thereof in the uterine cavity by a removal tool comprising amagnetic probe by means of which contact can be established with themagnetic members carried by the device and the latter withdrawn from theuterine cavity.

An additional object of the present invention is to provide a noveltwo-ring circular intrauterine device having a normally coiled tab inwhich is embedded at least one magnetic member and such device beingadapted readily to be deformed and inserted into the uterine cavity witha conventional applicator of the type capable of deforming the device tofacilitate passage of the same through the cervical canal.

Still another object of the invention is to provide an intrauterinedevice which is readily detectable in the body using magnetic orconventional x-ray techniques.

These and other objects of the invention will become apparent as thefollowing description proceeds in particular reference to theapplication drawings.

BRIEF DESCRIPTION OF THE APPLICATION DRAWING FIG. 1 comprises afragmentary view showing the intrauterine device of the presentinvention positioned within the uterine cavity;

FIG. 2 is a perspective view of the device constructed in accordancewith the present invention, shown positioned on an applicator;

FIG. 3 is a view generally similar to FIG. 1, showing the manner inwhich the magnetic probe functions to remove the device from the uterinecavity, with the device being illustrated in the initial stages of thewithdrawal; and a FIG. 4 is a'plan view similar to FIG. 1 showing amodified form of intrauterine device in accordance with the presentinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now in moredetail to the drawing, wherein like parts are indicated by likereference numerals, the

intrauterine device in accordance with the form thereof illustrated inFIGS. 1, 2 and 3 is generally indicated at and is shown in FIG. 1upwardly positioned fully within the uterine cavity 12, after passingthrough the cervical canal 14 in a manner to be described hereinbelow.

The intrauterine device 10 is in the form of a pair of concentricr ings10a, 1021 with bridging material 15 in the form of connector bridgespositioned therebetween and is preferably made of an inert plasticmaterial. The material must not only be inert in order to provide thenecessary compatibility, as noted above, but must also beelasticallydeformable to enhance insertion and removal of the devicefrom the uterine cavity. Although any material posessing thesecharacteristics may be employed, a particularly suitable material issilico-organic rubber, which is commercially available in one form underthe trademark SILASTIC, manufactured by the Dow Corning Company.

. The outer dimension, such as the diameter, perimeter or periphery, ofthe device 10 is preferably of a size which relates to that of theuterine cavity 12 so that the intrauterine device can perform itsintended function. Moreover, the diameter of the inner ring 10b ispreferably of a size to preclude detrimental side affects of such adevice, such as, for example, bowel strangulation or the like, thusprecluding entry into the device of such a body part. Moreover, thefairly large free or open 'spaces defined between respective rings andbridging 'material connecting the same as well as within the inner ringof the device 10 permits the uterus otherwise to function normally.

In the preferred form of the invention a normally coiled tab 16 iscoiled within the inner ring 10b of the device for purposes described inmore detail below. A member 17 of any suitable magnetic material, suchas stainless steel, which provides a magnetic field that exhibits amagnetic force on another magnet or a piece of magnetically responsivematerial or which is not a magnet itself but is responsive to themagnetic field of another magnet, is carried at the free end 18 of theresilient tab 16, the opposite end of which is integrally attached tothe inner ring 10b of the device 10. The tab 16 is molded or otherwiseformed so that it is normally coiled and nested within the body ring10b, as best shown in FIG. 1. The device 10 is inserted into the uterinecavity with the tab 16 coiled.

As shown in FIG. 2, the applicator, generally indicated at 20, forinserting the device 10 into the uterine cavity 12 is preferably formedof inert plastic material having a sufficient rigidity to perform theinserting function. A notch 22 formed at the top of the applicator isshaped to receive and cradle the inner ring 10b of the body of thedevice 10. Moreover, the second notch 24 is formed in the applicatorapproximately intermediate the ends thereof, with the notch including arelatively shallow entrance portion 26 and a retaining tip 28 whichfunctions to retain the ring when positioned in the notch. The spacingbetween the notches 22 and 24 is greater than the normal diameter of theinner ring 10b of the device, although, if desired, the applicator maybedesigned to cooperate similarly with the outer ring 10a. As a result,when the device is applied to the applicator as shown in FIG. 2, thedevice is radially deformed to generally eliptical shape, carried on theapplicator at the notches 22 and 24.

To insert the device 10 into the uterine cavity 12, the applicator withthe device mounted thereon is inserted upwardly through the cervicalcanal 14, with the radial deformation of the device facilitating suchpassage. When the device is wholly within the uterine cavity, theapplicator 20 is slightly rotated thereby freeing the applicator fromthe device, after which the device gradually regains its circular form.The applicator is then withdrawn and the device is left in place untilvoluntarily removed.

As shown in FIG. 3, the device 10 can be removed from the uterine cavityby a removing tool 30, which comprises a plastic rod-like body 32 and amagnetic probe 34 at one end thereof. The tool 30 is inserted into theuterine cavity until the magnetic probe 34 from which a magnetic fieldemanates contacts the free end 18 of the tab 16 which carries themagnetic member 17. The tool 30 is then withdrawn carrying the tab 16,as shown in FIG. 3. Thereafter, the tab can be physically grasped forremoval of the body comprising the concentric rings and bridgingmaterial of the device 10. As previously described, the elasticity ofthe device permits deformation thereof while passing through the lowerpart of the uterine cavity and the cervical canal so as not to causediscomfort.

Whereas the tab 16 functions as the conventional tail or string withregard to facilitating removal of the device, the tabs naturalresiliency causes it to remain in a nested position within the body ofthe device 10 while the latter is in the uterine cavity. In this way theusual irritation and side affects associated with the presence of astring or tail are avoided.

Manufacture of the intrauterine device illustrated in FIGS. 1, 2 and 3can be by several means. For example, the tab end coiled shape can bemolded simultaneously within the body of the device 10. Alternatively, amember can be molded from which the tab and body are formed as bycutting the member to the configuration desired.

Turning now briefly to FIG. 4, a modified form of the invention is showncomprising a main body 40 comprising outer and inner rings 40a, 40bcoupled by connector bridges 41 defining the intrauterine device andmolded in the outer ring 40a of the body there are a plurality ofmagnetic segments commonly designated at 42, there being four suchsegments shown, equally spaced circumferentially around the outer ring.The segments 42 can be made of any suitable magnetic material asdescribed, for example, above. It will be understood that the magneticsegments could be more or less in number, and differently spaced withinthe device. The critical aspect of the invention is that the segmentsare spaced sufficiently far apart, with sufficient interveningsilico-organic rubber material to render the device readily deformable.Alternatively, the segments or embedded magnetic material in eitherembodiment can be flexible in nature, for instance in the form of coiledwire or granular magnetic material embedded in the rubber.

Insertion of the modified form of the device into the uterine cavity issimilar to that described above with reference to the preferred form ofthe invention using the applicator shown in FIG. 2. When the device 40of FIG. 4 is to be removed from the uterine cavity, the removal tool 30is inserted upwardly into the uterine cavity and contact is made withthe device. The magnetic probe 34 is then moved along the circumferenceof the device till it is at or adjacent one of the magnetic segments 17whereupon the device is magnetically coupled to the tool 30 for removalfrom the uterine cavity. The elasticity of the inert plastic materialpermits the deformation of the device 40, whereby the device can beremoved from the uterine cavity without discomfort.

The advantages of the present invention should be apparent from theabove description. The material employed for the device is totally inertand relatively soft and flexible, thereby eliminating the heretoforeexisting problem of infection, bleeding, and discomforts associated withdevices of this general type. The shape of the device and the relativeflexibility thereof functions to prevent the spontaneous expulsion ofthe device from the uterine cavity. The elasticity of the device alsopermits the same to be readily inserted in or removed from the uterinecavity without encountering difficulties normally associated withintrauterine devices currently available.

An additional, significant advantage of the present invention is thetotal absence of a string or tail attached to the device as in mostcurrently available forms. The need for a conventional string or tail isremoved by the incorporation into the device of magnetic means in anormally coiled tab or in the body of the device itself which can becoupled to the magnetic probe of the removal tool for withdrawing thedevice from the uterine cavity. The irritation and associated sideaffects due to the presence of a string or tail are therefore eliminatedin accordance with the present invention.

A further advantage of the invention is that the tworing arrangementprovides an outer ring of sufficient diameter to perform the requiredfunction of the device while the inner ring is sufficiently small toavoid strangulation of body parts or similar detrimental effects and therelatively large open spaces within the confines of the device permitnatural occurrence of normal uterine body functions. Moreover, shouldthe device become lost in the body, it can be easily detected by x-rayequipment or by a magnetic detector, which avoids the need for exposingthe patient to x-rays.

Whereas the invention has been described with reference to a circularconcentric ring intrauterine device, principles of the invention can beapplied to devices of other shapes. In particular, the relationship ofembedded magnetic material to molded rubber material is such that atleast a portion of the device regardless of the shape is sufficientlyeasily deformed that it can be readily removed from the uterine cavitywith a magnetic probe. However, the natural resiliency of that portionis such that it resumes a natural shape, when in the uterine cavity, bywhich irritation and side affects are avoided.

The embodiments of the invention in which an exclusive property orprivilege is claimed are defined as follows:

1. An intrauterine device adapted to be inserted in the female uterinecavity comprising a member made of elastic substantially inert material,said member including generally concentric inner and outer rings coupledby a plurality of connector bridges, and means formed of magneticmaterial carried in said device, said device being capable ofdeformation for insertion through the cervical canal into said cavitywhere it re gains its original form when released therein and of removalby magnetic coupling with magnetic extractor means, a tab integrallyjoined at one end thereof to said member and normally coiledtherewithin, with said magnetic material being carried by the free endof said tab for extension of the tab and removal of the member by theextractor means.

2. The device of claim 1, wherein said tab is integrally joined to saidinner ring.

3. The device of claim 2, wherein said tab is normally coiled withinsaid inner ring.

4. The device of claim 1, wherein said elastic substantially inertmaterial comprises silico-organic rubber.

5. The device of claim 1, wherein said rings comprise circular rings.

6. The device of claim 1, wherein said plurality of connector bridgescomprise four connector bridges.

7. The device of claim 1, wherein said ring, connec tor bridges andnomally coiled tab are substantially coplanar.

8. An intrauterine device adapted to be inserted in the female uterinecavity comprising a body made of an elastic substantially inertmaterial, said body including concentric inner and outer rings coupledby a plurality of connector bridges, magnetic material embedded withinat least a portion of said material, said portion being sufficientlydefonnable that it is readily removable from the uterine cavity byengagement of the magnetic material with a magnetic probe; said portionhaving sufficient resiliency that it assumes a natural shape when in theuterine cavity by which irritation and side affects are avoided; andfurther comprising a normally coiled resilient tab having one endintegral with one of said rings, said tab having a free end, and themagnetic material being at said tab free end.

9. The device of claim 8, wherein said elastic substantially inertmaterial comprises silico-organic rubber.

1. An intrauterine device adapted to be inserted in the female uterine cavity comprising a member made of elastic substantially inert material, said member including generally concentric inner and outer rings coupled by a plurality of connector bridges, and means formed of magnetic material carried in said device, said device being capable of deformation for insertion through the cervical canal into said cavity where it regains its original form when released therein and of removal by magnetic coupling with magnetic extractor means, a tab integrally joined at one end thereof to said member and normally coiled therewithin, with said magnetic material being carried by the free end of said tab for extension of the tab and removal of the member by the extractor means.
 2. The device of claim 1, wherein said tab is integrally joined to said inner ring.
 3. The device of claim 2, wherein said tab is normally coiled within said inner ring.
 4. The device of claim 1, wherein said elastic substantially inert material comprises silico-organic rubber.
 5. The device of claim 1, wherein said rings comprise circular rings.
 6. The device of claim 1, wherein said plurality of connector bridges comprise four connector bridges.
 7. The device of claim 1, wherein said ring, connector bridges and nomally coiled Tab are substantially coplanar.
 8. An intrauterine device adapted to be inserted in the female uterine cavity comprising a body made of an elastic substantially inert material, said body including concentric inner and outer rings coupled by a plurality of connector bridges, magnetic material embedded within at least a portion of said material, said portion being sufficiently deformable that it is readily removable from the uterine cavity by engagement of the magnetic material with a magnetic probe; said portion having sufficient resiliency that it assumes a natural shape when in the uterine cavity by which irritation and side affects are avoided; and further comprising a normally coiled resilient tab having one end integral with one of said rings, said tab having a free end, and the magnetic material being at said tab free end.
 9. The device of claim 8, wherein said elastic substantially inert material comprises silico-organic rubber. 